Shots: The US FDA has accepted sNDA & granted priority review to Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA-mutated mHSPC sNDA was backed by P-III (AMPLI...

Shots: Merck has reported P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in Pt-resistant recurrent ovarian cancer pts...

Shots: China’s NMPA has accepted NDA of Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had an inadequate response or are unamenable to topical...

Shots: Leads Biolabs has granted Dianthus exclusive global rights to develop, manufacture, & commercialize LBL-047 as DNTH212 outside of Greater China As per the deal, Dianthus will get $20M upfront,...

Shots: EVOQ Therapeutics has entered into a collaboration & license agreement with Sanofi to advance EVOQ’s NanoDisc tech in immunology As per the deal, both companies will jointly lead research...

Shots: Biocon Biologics has expanded its strategic collaboration with Civica to commercialize Insulin Glargine in the US Biocon Biologics & Civica entered into a multi-year exclusive distributorship...

Shots: Health Canada has approved Opzelura cream 1.5% for the treatment of mild to mod. AD in children (≥2yrs.), when other topical therapies are ineffective or unsuitable Approval was based on the...

Shots: The 2 P-III (ACHIEVE-2 & 5) trials assessed orforglipron (3, 12 & 36mg; QD) vs dapagliflozin (10mg; QD) in 962 adults with T2D uncontrolled on metformin, & vs PBO in 546 adults with T2D...

Shots: Novartis has reported the P-III (APPLAUSE-IgAN) trial findings assessing Fabhalta (200mg; BID; PO) vs PBO, both on top of SoC in 477 adults with IgA nephropathy (IgAN) Trial showed that...

Shots: BI has entered into a global collaboration & licensing agreement with AimedBio to develop a novel ADC for a broad range of cancers, expanding NBE Therapeutics’ portfolio (BI subsidiary) As per...

Shots: Novo Nordisk has entered into a definitive asset purchase & license agreement with Omeros to develop zaltenibart (MASP-3 inhibitor) for rare blood & kidney disorders, while Omeros retains...

Shots: Vara has received the European CE Mark approval for its breast imaging AI to operate as an independent second reader for both screening & diagnostic use, with EU availability starting Oct 15,...

Shots: insitro & BMS have extended their 5yr. collaboration (2020) to discover novel small molecule therapies for ALS using insitro’s AI-enabled ChemML platform The 1yr. extension will focus on...

Shots: The EMA has received MAA of relacorilant for the treatment of Pt-resistant ovarian cancer MAA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated...

Shots: BioCryst Pharmaceuticals has entered into a definitive agreement to acquire Astria Therapeutics, strengthening its allergic & immunology portfolio As per the deal, Astria shareholders will...

Shots: Pfizer has reported P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy for pts with HER2+ MBC...

Shots: The P-III (CONVOKE) trial assessed CT-155 (BI 3972080) vs a digital control app as an adjunct to SoC antipsychotic therapy in pts (≥18yrs.) with experiential negative symptoms of schizophrenia...

Shots: Nabla Bio has entered into a multi-year research collaboration with Takeda to advance AI-driven design of protein therapeutics, leveraging Nabla Bio’s Joint Atomic Model (JAM) Nabla Bio will...

Shots: SystImmune has dosed the first patient with izalontamab brengitecan (iza-bren) in the global P-II/III (IZABRIGHT-Breast01) study for previously untreated TNBC ineligible for anti-PD-(L)1 drugs...

Shots: China’s NMPA has approved Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster) in adults (≥18yrs.) at increased risk due to immunodeficiency or immunosuppress...